CTA Submission Manager

Location: London (The Westworks)

Salary Range

£47,540.50 - £88,289.50

Job Description Summary

#LI-Hybrid

Primary Location: London, United Kingdom (for candidates residing within 50 miles of the office)

Other Locations: Remote, United Kingdom (UK based candidates living more than 50 miles from the office)

Relocation Support: This role is based in London, United Kingdom. Novartis is unable to offer relocation support: please only apply if accessible.

Help shape the path from clinical development to patients by bringing regulatory precision to every submission. As CTA Submission Manager, you’ll manage regulatory activities for clinical trial applications across an assigned portfolio, working closely with study teams, country leads and cross-functional partners. You’ll use your regulatory expertise to anticipate challenges, strengthen submissions and help secure timely approvals, while contributing to continuous improvement across Regulatory Affairs.

Key Responsibilities

• Lead high-quality clinical trial application submissions, ensuring alignment with regulatory requirements and internal processes.
• Build strong regulatory knowledge across your assigned product portfolio and relevant markets.
• Identify regulatory risks, gaps and trade-offs early to support timely submissions and approvals.
• Coordinate responses to Health Authority queries, developing robust justifications with regulatory and cross-functional partners.
• Maintain accurate product information within regulatory compliance and information management systems.
• Support preparation and finalisation of documentation for Health Authority interactions.
• Contribute to continuous improvement, simplification and automation initiatives across Regulatory Affairs.
• Additional Locations: Home Worker